Safety and Efficacy of an Anti-Psychotic in Patients With Schizophrenia

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (Industry)

Overall Status

Completed

CT.gov ID

NCT00074477

Collaborator

(none)

250

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the efficacy (how well the drug works), safety, and side effects of paliperidone palmitate injection compared to placebo in the treatment of the symptoms of schizophrenia in adults. The placebo used in this study was a nutritional substance known as 20% Intralipid emulsion given to patients requiring intravenous feedings.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: R092670	Phase 2

Detailed Description

Paliperidone palmitate is an aqueous suspension that releases paliperidone gradually over a period of about 1 month and is under development to provide a sustained and stable level of paliperidone. This is a randomized (patients will be assigned to different treatment groups based solely on chance), double-blind (neither the patient nor the physician will know if placebo or drug is being given and at what dose), placebo-controlled, multicenter study in patients with schizophrenia. The study consists of a screening period (maximum 5 days, including a 3-day washout of psychotropic medications other than antidepressants, if applicable); a 7-day, open-label, oral run-in period; and a 64-day double-blind treatment period. The total duration of the study is approximately 11 weeks. Efficacy will be evaluated during the study using the Positive and Negative Symptom Scale for Schizophrenia (PANSS) and the Clinical Global Impression - Severity (CGI-S) scale. Safety will be evaluated by monitoring adverse events and changes in clinical laboratory results, including prolactin levels; physical examination results; tardive dyskinesia will be rated using the Abnormal Involuntary Movement Scale (AIMS), akathisia will be rated according to the Barnes Akathisia Rating Scale (BARS), extrapyramidal symptoms will be evaluated using the Simpson-Angus Rating Scale (SAS); electrocardiogram (ECG); vital sign measurements; and concomitant therapy. ER OROS paliperidone (6 or 12 mg) or IR paliperidone (2 or 4 mg) oral dosage administered daily for 7 days (Day -7 to -1), followed by i.m. injections of paliperidone palmitate (either 50 mg eq. or 100 mg eq.), or placebo on Days 1, 8, and 36 of the study.

Study Design

Study Type:

Interventional

Actual Enrollment :

250 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of 50 and 100 Mg-eq of Paliperidone Palmitate in Patients With Schizophrenia

Study Start Date :

Oct 1, 2003

Actual Study Completion Date :

Jul 1, 2004

Outcome Measures

Primary Outcome Measures

The change in total PANSS score from the start of the double-blind treatment period to the end of the double-blind treatment period. []

Secondary Outcome Measures

Changes from the start of to the end of the double-blind treatment period in CGI-S and in the PANSS subscales for specific symptoms. Incidence of adverse events, labs and ECGs throughout study. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients diagnosed with schizophrenia
for at least 1 year before screening
meet PANSS score criteria
must agree to hospitalization for a minimum of 14 days
body mass index (BMI) <35.0 kilogram (kg)/meter (m)2.

Exclusion Criteria:

Patients who are involuntarily committed as in-patients
have a DSM-IV Axis I diagnosis other than schizophrenia
have a DSM-IV diagnosis of substance dependence within 3 months before screening (nicotine, caffeine dependence, and history of recreational use of marijuana are not exclusionary)
have a decrease of >/=25% in the PANSS score between screening and predose
previous lack of response to 2 adequate trials of antipsychotic treatment
have a significant risk of suicidal, homicidal, or violent ideation or behavior
have severe gastrointestinal narrowing (pathologic or iatrogenic)
current presence of any significant or unstable medication condition
treatment with any protocol disallowed therapies
clinically significant result from screening laboratory or ECG.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators

Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.